Columbia Analytical Services

Pharmaceutical and Nutraceutical Analytical Services at CAS

The CAS - Kelso laboratory is cGMP compliant and registered with the FDA. CAS’ comprehensive quality assurance and ethics programs ensure that data produced is scientifically sound, legally defensible, and accurately documented. To ensure that your analytical needs are met, your project is managed by one of our in-house project chemists. Our capabilities, expertise, and services include the following:

Monograph Testing – USP/NF, EP, JP, and BP monograph testing. This includes raw material and final product testing. An example of this includes Organic Volatile Impurities testing by USP <467>. CAS can also complete testing using client supplied methodology.

Method Development and Validation – Our professional scientists have extensive experience in analytical chemistry and can assist in method development and validation for pharmaceutical testing. Methods are validated to current ICH and USP guidelines.

Engineering Studies/Process Validation – Scientists at CAS are accustomed to non-routine testing and have the knowledge and resources to solve your analytical problems. Examples of this include analytical support for cleaning studies or manufacturing processes.

Stability Testing – CAS provides analytical support to your stability study testing. This may include assay testing, physical testing, and impurity and degradation product monitoring. This also includes development and validation of stability indicating assays.

CAS has extensive instrumental testing capabilities. CAS’ general analytical capabilities include the following: Karl Fischer, Gas Chromatography, Gas Chromatography/Mass Spectrometry, High- Performance Liquid Chromatography, Inductively Coupled Plasma/Mass Spectrometry, Inductively Coupled Plasma/ Atomic Emission Spectroscopy, Atomic Absorption, LC/MS/MS (currently being installed), and many general chemistry techniques.

Our services will help to keep your turn-around-times ahead of schedule, costs under budget, and most importantly meet cGMP quality and regulatory requirements.

Learn more about pharmaceutical testing…

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